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Adenoma, Liver CellPhase 2NCT02582034

Internal Radiation Therapy for Hepatocellular Carcinomas With Therasphere: Optimized Dosimetry Versus Standard Dosimetry

A Phase 2 study testing Optimized Internal Radiation Therapy and Standard Internal Radiation Therapy in people with Adenoma, Liver Cell, run by Center Eugene Marquis at 4 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine whether a treatment with Therasphere which is optimized is more efficient compared to a standard treatment for patients suffering from hepatocellular carcinomas. Read more about this study

Who is it for?
Any age
Conditions the study is for
Adenoma, Liver Cell
What is being tested?
Optimized Internal Radiation Therapy and Standard Internal Radiation Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
4 sitesFrance
Study dates
Dec 2015to Dec 2018
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Age ≥ 18,
  • Written free and informed consent,
  • Histologically demonstrated Hepatocellular Carcinoma (HCC), not a candidate for surgery or local ablative treatment (radio frequency, etc.)
  • Barcelona Clinic Liver Cancer (BCLC) classification A, B or C,
  • At least one lesion ≥ 7 cm,
  • Hepatic reserve (hepatic parenchyma not treated) after the first SIRT ≥ 30%,
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  • Unilateral involvement, minimal bilateral involvement allowed only with a hepatic reserve ≥ 30% after SIRT
  • Child A classification only, or B but with bilirubinemia <35 micromol/L,
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1,
  • Patients whose biological parameters meet the following criteria:
  • Hemoglobin ≥ 8.5 g/dL,
  • Granulocytes ≥ 1500/mm3,
  • Platelets ≥ 50,000/mm3,
  • Bilirubinemia <35 micromol per liter,
  • Transaminases ≤ five times the upper limit of normal,
  • Creatininemia ≤ 1.5 times the normal upper limit,
  • Expected survival over 12 weeks,
  • Negative pregnancy test for women of childbearing age,
  • If sorafenib has been taken the diagnostic angiogram must follow it by at least four weeks after its stop.

Who cannot join

  • HCC operable or accessible to a local ablative treatment (radio frequency),
  • Hepatectomy history unless a segmental treatment is considered, with a hepatic reserve ≥ 30% after SIRT,
  • Prior treatment with sorafenib unless stopped at least four weeks earlier,
  • History of chemo-embolization of the principal lesion, except in case of nodular residual lesion measuring at least 7 cm or in case of progression after initial response,
  • Bilateral disease requiring a whole liver injection or with a hepatic reserve < 30% after SIRT
  • Treatment of another cancer less than one year earlier,
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  • Extra-hepatic metastases other than adenopathies of the hilum smaller than 2 cm,
  • >70% tumor invasion of the liver,
  • Bilirubinemia ≥ 35 µmol/L,
  • A Severe underlying biliary pathology:
  • Bile duct anomaly (stent, dilation) Cirrhosis of biliary origin,
  • Women of childbearing age without contraception
  • Pregnant or nursing women

Trial locations and contacts

4 sites in 1 country.

France4 sites

  • CHU Henri Mondor

    Créteil, 94000

  • CHU Saint Eloi

    Montpellier, 34925

  • Centre Eugène Marquis

    Rennes, 35042

  • Gustave Roussy

    Villejuif

Other trials in France

About this study

Official title: Selective Internal Radiation Therapy for Hepatocellular Carcinomas With Yttrium-90 Loaded Microspheres: Optimized Dosimetry Versus Standard Dosimetry

The purpose of this study is to determine whether a treatment with Therasphere which is optimized is more efficient compared to a standard treatment for patients suffering from hepatocellular carcinomas.

Read the detailed description

For patients suffering from hepatocellular carcinoma, a palliative treatment can be proposed if tumor expansion is limited to the liver. One of palliative treatment is the the Selective Internal Radiation Therapy (SIRT) with Therasphere®. This treatment is made secure by performing a diagnostic angiogram coupled with a hepatic perfusion scintigraph with which patients at risk of complications are identified and excluded. The treatment objective, with the standard dosimetric approach, is to deliver an absorbed dose of 120 ± 20 Gy to the treated hepatic volume, most often one lobe. Recent retrospective trials show that an optimized dosimetric approach, considering the dose absorbed by the tumor, is technically achievable and would probably make it possible to obtain a better effectiveness. In our experience, treatment personalisation have been described to be used for 60% of the patients with a tumor larger than 7 cm underlying the clinical impact of this new approach.

Being tested
Optimized Internal Radiation Therapy, Standard Internal Radiation Therapy
Keywords
Optimized Dosimetry versus standard Dosimetry, Internal Radiation Therapy
Medical subject headings
Adenoma, Liver Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Optimized Internal Radiation TherapyRadiation

    Injection of yttrium-90 microspheres (TheraSphere®) is performed during the therapeutic angiogram, directly into the hepatic artery (left or right, or even segmental).

    Optimized dosimetry arm: the activity to be administered is calculated so as to deliver predictive dosimetry:

    • An absorbed dose to the tumor of at least ≥ 205 Gy and if possible exceeding 250 Gy or even 300 Gy
    • A dose at the treated healthy liver < 120 Gy in case of lobar treatment
    • Dose to the treated healthy liver can exceed 120 Gy in case of segmental treatment and hepatic reserve > 30%
    • A pulmonary dose < 30 Gy for one treatment and < 50 Gy in cumulative dose in case of multiple treatments.

  • Standard Internal Radiation TherapyRadiation

    Injection of yttrium-90 microspheres (TheraSphere®) is performed during the therapeutic angiogram, directly into the hepatic artery (left or right, or even segmental).Standard dosimetry arm: the activity to be administered is calculated so as predictive dosimetry:

    • An absorbed dose of 120 ± 20 Gy to the treated volume (whatever the tumor absorbed dose)
    • A pulmonary dose < 30 Gy for one treatment and < 50 Gy in cumulative dose in case of multiple treatments.
Study groups in NCT02582034
Study groupRoleWhat they receive
Standard dosimetryActive comparatorStandard Internal Radiation Therapy : Dose of radiation delivered to the tumoral volume is fixed : 120 Gray (GY)
Receives: Radiation: Standard Internal Radiation Therapy
Optimized dosimetryExperimentalOptimized Internal Radiation Therapy : Dose of radiation absorbed by the tumor is > 205 GY, if possible 250 or 300 Gy.
Receives: Radiation: Optimized Internal Radiation Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The primary endpoint is to compare the response rate of the treated lesion at the first radioembolization, evaluated using European Association for the Study of the Liver (EASL) criteria of yttrium-90 marked glass microspheres SIRT

    Measured: 3 months after treatment administration

Secondary outcomes (5)

  1. Progression Free Survival

    Measured: Up to 12 months

  2. Overall survival

    Measured: Up to 30 months after inclusion of the 1st patient

  3. Related Adverse Events in both arms as assessed by National Cancer Institute criteria (National Cancer Institute Common Terminology Criteria for Adverse Events, (NCI CTCAE) version 4).

    Measured: Up to 12 months

  4. Progression free survival not accessible to SIRT

    Measured: Up to 12 months after treatment administration

  5. Post-therapeutic dosimetry measured by Positron emission tomography-computed tomography PET / CT

    Dose delivered to the treated liver, the tumors, healthy liver and lings

    Measured: Day one of treatment administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2015 (estimated)
  2. Study startDec 2015
  3. Primary completionDec 2018
  4. Study completionDec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02582034
Sponsor's protocol ID
DOSISPHERES-01
Status last verified
Jan 2019
First submitted
9 Oct 2015
Last updated
31 Jan 2019
Results posted
No
Data monitoring committee
No

Publications

  • Garin E, Tselikas L, Guiu B, Chalaye J, Rolland Y, de Baere T, Assenat E, Tacher V, Palard X, Deandreis D, Mariano-Goulart D, Amaddeo G, Boudjema K, Hollebecque A, Meerun MA, Regnault H, Vibert E, Campillo-Gimenez B, Edeline J. Long-Term Overall Survival After Selective Internal Radiation Therapy for Locally Advanced Hepatocellular Carcinomas: Updated Analysis of DOSISPHERE-01 Trial. J Nucl Med. 2024 Feb 1;65(2):264-269. doi: 10.2967/jnumed.123.266211.

    PubMed 38212068

  • Garin E, Tselikas L, Guiu B, Chalaye J, Edeline J, de Baere T, Assenat E, Tacher V, Robert C, Terroir-Cassou-Mounat M, Mariano-Goulart D, Amaddeo G, Palard X, Hollebecque A, Kafrouni M, Regnault H, Boudjema K, Grimaldi S, Fourcade M, Kobeiter H, Vibert E, Le Sourd S, Piron L, Sommacale D, Laffont S, Campillo-Gimenez B, Rolland Y; DOSISPHERE-01 Study Group. Personalised versus standard dosimetry approach of selective internal radiation therapy in patients with locally advanced hepatocellular carcinoma (DOSISPHERE-01): a randomised, multicentre, open-label phase 2 trial. Lancet Gastroenterol Hepatol. 2021 Jan;6(1):17-29. doi: 10.1016/S2468-1253(20)30290-9. Epub 2020 Nov 7.

    PubMed 33166497

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Optimized Internal Radiation Therapy and Standard Internal Radiation Therapy in people with Adenoma, Liver Cell, run by Center Eugene Marquis at 4 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary endpoint is to compare the response rate of the treated lesion at the first radioembolization, evaluated using European Association for the Study of the Liver (EASL) criteria of yttrium-90 marked glass microspheres SIRT (time frame: 3 months after treatment administration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02582034, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2019.

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